Why it was recalled
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Product description
Diocto Syrup (docusate sodium), 60 mg/15 mL, One Pint (473 mL) bottle, Dist. by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0536-1001-85.
Lot numbers, UPCs & expiration codes
Lot #: 22941505, Exp 10/17; 229416601, Exp 01/18; 22941602, Exp 03/18
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1524-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 8, 2016
- FDA report date
- Oct 5, 2016
- Quantity
- 19,656 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pharmatech LLC
Original FDA data
Every field from FDA enforcement report D-1524-2016, exactly as published.
Show all FDA fields
- City
- Davie
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 74874
- Address
- 4131 Sw 47th Ave
- Address (line 2)
- Suite 1403
- Code information
- Lot #: 22941505, Exp 10/17; 229416601, Exp 01/18; 22941602, Exp 03/18
- Postal code
- 33314-4026
- Report date
- Oct 5, 2016
- Product type
- Drugs
- Recall number
- D-1524-2016
- Classification
- Class II
- Recalling firm
- Pharmatech LLC
- Product quantity
- 19,656 bottles
- Termination date
- Sep 23, 2024
- Reason for recall
- CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Diocto Syrup (docusate sodium), 60 mg/15 mL, One Pint (473 mL) bottle, Dist. by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0536-1001-85.
- Distribution pattern
- Nationwide
- Recall initiation date
- Aug 8, 2016
- Initial firm notification
- Letter
- Center classification date
- Sep 27, 2016